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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 050805/S-007
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Galderma Laboratories, L.P.
`Attention: Richard Almond
`Senior Manager Regulatory Affairs
`14501 North Freeway
`Fort Worth, TX 76177
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`Dear Mr. Almond:
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`Please refer to your Supplemental New Drug Application (sNDA) dated May 7, 2012, received
`May 8, 2012, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`(FDCA) for Oracea (doxycycline) Capsules, 40 mg.
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`We acknowledge receipt of your amendments dated September 17 and 20, October 24 and
`October 31, and November 7, 2012.
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`This “Prior Approval” supplemental new drug application provides for updates to the label to
`reflect data from a mouse carcinogenicity study conducted with doxycycline.
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`We have completed our review of this supplemental application, as amended. It is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`text.
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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
`automated drug registration and listing system (eLIST), as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert), with the
`addition of any labeling changes in pending “Changes Being Effected” (CBE) supplements, as
`well as annual reportable changes not included in the enclosed labeling.
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`Information on submitting SPL files using eLIST may be found in the guidance for industry
`titled “SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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`The SPL will be accessible from publicly available labeling repositories.
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`Reference ID: 3214183
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` NDA 050805/S-007
`Page 2
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`Also within 14 days, amend all pending supplemental applications for this NDA, including CBE
`supplements for which FDA has not yet issued an action letter, with the content of labeling
`[21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the changes approved in this
`supplemental application, as well as annual reportable changes and annotate each change. To
`facilitate review of your submission, provide a highlighted or marked-up copy that shows all
`changes, as well as a clean Microsoft Word version. The marked-up copy should provide
`appropriate annotations, including supplement number(s) and annual report date(s).
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Rachel Attinello, Office Automation Clerk, at (301) 796-0637.
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`Sincerely,
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`{See appended electronic signature page}
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`Tatiana Oussova, MD, MPH
`Deputy Director for Safety
`Division of Dermatology and Dental Products
`Office of Drug Evaluation III
`Center for Drug Evaluation and Research
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`ENCLOSURE:
`Content of Labeling
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`Reference ID: 3214183
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`TATIANA OUSSOVA
`11/07/2012
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`Reference ID: 3214183
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